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2017-43602

2017-43602

Title 
Global Training Specialist – Drug Safety & Pharmacovigilance
Job Locations 
-
US-MA-Boston
US-IL-Chicago
US-PA-Blue Bell
US-VA-Charlottesville
US-NC-Raleigh
Posted Date 
1/10/2018

More information about this job

Overview

Designs, delivers and evaluates Oracle Argus database and other PRA safety systems training for global Safety & Risk Management (SRM), and/or Drug Safety / Pharmacovigilance staff to meet corporate goals and to improve upon safety information collection. Ensures that training is delivered in accordance with regulatory requirements and corporate policies.

Responsibilities

  • Deliver high-quality training activities for global Safety & Risk Management staff, including, but not limited to: new hire training, system, regulation and process training.
    • Evaluates knowledge, skill and ability level of staff pre- and post-training.
  • Evaluates and reports on training effectiveness in improving employee and/or process performance.
  • Under the guidance of the directors and subject matter experts in SRM, develop, and continually improve training on Pharmacovigilance regulations as well as PRA SRM procedures, processes and systems for existing staff, as appropriate via net meetings, web conferencing (i.e. WebEx) or face to face.
  • Provides Oracle Argus database expertise and training to other PRA personnel, as appropriate
  • Support trending analyses on data collected through QC activities and identify areas of potential training needs
  • Provide compliance support by answering questions or providing advice on PRA SRM procedures, processes, systems, and tools
  • Support the development, maintenance, distribution, and continually improvement of tools (e.g. Quick Reference Guides, Checklists, etc.) to improve staff efficiency or compliance
  • Assist with implementation of process and efficiency improvements
  • Support SRM staff in preparing for internal or external audits
  • May be responsible for drafting a Quality & Training Plan for an assigned program or functional group
  • May be involved in reviewing, revising, or drafting controlled documents or written guidance for PRA SRM related processes.
  • Support other relevant global pharmacovigilance systems and related business processes as need to enhance efficiency and provide training support.

Qualifications

•6+ years relevant industry experience (CRO or pharmaceutical)
   o Advanced knowledge in Pharmacovigilance and the regulatory environment governing safety and risk management activities.
   o Substantial pharmaceutical or CRO experience including project leadership and management, preferred.

•3-5 years of experience in working with Oracle Argus Safety Database System

•3-5 years of experience in Training and/or Quality positions, desired
   o Experience in the design, delivery, and evaluation of training courses or programs. Working knowledge of training management software, preferred.

•An undergraduate degree or its international equivalent from an accredited institution. Focus area in in clinical, science, or health-related field.
   o An advanced degree in education, organizational development, business, clinical, science or health-related or its international equivalent, preferred.

•Read, write, and speak fluent English; fluent in host country language required.

•Up to 40-50% travel required for this position (mainly domestic); travel to be heaviest during first six months.

 

LOCATIONS:
This role will report to one of the following offices:

 

U.S: Raleigh, NC; Charlottesville, VA; Blue Bell, PA (greater Philadelphia area); greater Chicago, IL area; or greater Boston, MA area

Europe: Reading, UK or Mannheim, Germany.

PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

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